AccessGUDID - DEVICE: Gold Standard Diagnostics Is-CMV IgG ELISA Test Kit (B3507203200)

GUDID

Device Identifier (DI) Information

Brand Name: Gold Standard Diagnostics Is-CMV IgG ELISA Test Kit
Version or Model: 720-320
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 720-320
Company Name: Gold Standard Diagnostics Corporation

Primary DI Number: B3507203200
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790524891 *Terms of Use

Device Description: ImmunoSimplicity (Is) CMV IgG Test for the detection of IgG antibodies to cytomegalovirus (CMV) as an aid in the assessment of the patient's immunological response to CMV and to determine the immune status of individuals.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
49712	Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to cytomegalovirus (CMV) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LFZ	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K981163	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a5bb5d21-fe85-4a9c-8420-e78a53158c5c
Public Version Date: June 04, 2021
Public Version Number: 2
DI Record Publish Date: June 03, 2020